This blog began in 2007, focusing on anthrax vaccine, and later expanded to other public health and political issues. The blog links to media reports, medical literature, official documents and other materials.

Wednesday, December 9, 2009

The vaccine/bioterrorism industry is expert at making silk purses out of sows' ears. Novartis, the company that failed to get its 50% share of swine flu vaccine out in a timely manner, and has a long history of vaccine failures, received a $400 million grant to open a vaccine plant in the US.However, the University of Minnesota informs us that HHS has actually invested $767 million in Novartis' development of the technology and building costs.

Progress has been made, Sibelius said. A new facility that can make flu vaccine using cells instead of eggs opened last week in Holly Springs, N.C., after Novartis received more than $400 million in federal funding. But that factory would still be able to produce perhaps only half the vaccine the nation would need in a pandemic, and that process is still prone to delays, she said.

"There are gaps at every stage in the process, from the laboratory to the factory floor, that are slowing or stalling the development of key countermeasures," Sebelius said, referring to the nation's reliance on research conducted at the National Institutes of Health and the Defense Department, which is often not focused on government priorities, as well as the lack of incentive for companies to invest in making new products for public health emergencies.

"In this age of growing public health threats against which countermeasures are often our best defense, that's dangerous," she said.

Novartis has kept a very close hold on the clinical data generated by its MF59 (squalene-containing) adjuvant, both in terms of effectiveness and safety. A French review in Prescrire that I cited months ago found increased side effects but no increased efficacy when MF59-containing flu vaccines were used in the elderly, the only group for which it is approved. I previously cited a statement from FDA indicating concern with the presence of extraneous DNA in vaccine made from the canine kidney cell line to be used by Novartis at the new factory.

The plant has been built and can start making MF59 this month, even though its vaccine production method has not received FDA approval yet, nor has the use of MF59 in US vaccines ever been approved.

But with nearly $800 million of US government money already invested in the Novartis facility, and a roughly equivalent amount invested in 4 other firms' cell-based vaccine development, is there any doubt FDA approval will be forthcoming?

MedImmune, which makes nasal-spray seasonal and pandemic H1N1 flu vaccines, has put its cell-based development efforts on hold, Dr. George Kemble, the company's vice president for research and development, said today.

Kemble said the company has a disagreement with the Food and Drug Administration (FDA) over the direction of clinical trials for its cell-based flu vaccine. MedImmune officials were aiming to conduct trials to determine if cell-based and egg-based versions of the same vaccine were equally immunogenic, he said.

But the FDA said it wanted the company to proceed with an efficacy trial to determine if the cell-based vaccine actually protects people from seasonal flu. "That added years and hundreds of millions of dollars to the program," he said. [Imagine that! The company was being held to an honest efficacy standard by FDA, instead of being allowed to squeak through licensure using cherry-picked surrogate markers--and has the temerity to complain about it!--Nass]

In view of the FDA's position, Kemble said MedImmune decided to "take a step back," reevaluate the program, and discuss it with HHS officials before deciding what to do next. [Does this mean they will try to go around FDA to get the go-ahead from its parent agency?--Nass]

After swimming with dolphins at Key Largo, they checked me out at the edge of the pool

Visiting a Bhutanese Dzong, the regional seat of both government and religion (and a fort for good measure)

Why am I blogging?

Because life is meant to be lived! The left side of this blog has photos of some peak experiences. And the right side contains information about which I am passionate.

Too many peoples' lives are characterized by lack of authenticity, and fear of acknowledging and expressing their true nature. Employees cannot say what they think at work, and in the corporate system we must squish ourselves into square holes when we are round pegs. We thus lose touch with our souls, becoming cogs in a soulless, profit-driven machine.

The culture of political correctness has meant, in medicine, that we ignore how the foundations of our science are being undermined by commercialism. Clinical data generated or presented by the manufacturers of drugs, vaccines and devices cannot be trusted: there are hundreds of studies proving this. But this fraudulent information continues to be the only data informing the approval of vaccines, drugs and devices.

Unless scrupulous ethical conduct is demanded of physicians and biological scientists, our lack of meaningful standards will carry the medical-pharmaceutical system down the path of increasing irrelevance.

Medicine and its tools need to be affordable. The current medical-industrial milieu, characterized by contempt for science, countless ways for insiders to achieve wealth due to failure of good governance, and regulatory agency-to-industry revolving doors, has ushered in stratospheric pricing... further kicking us down that path to irrelevance.

Why is our new health care plan a giveaway to health industries instead of to health consumers? Why won't it cover all Americans? Why was the "public option" never an option for the Obama administration? Why did the promised Trump health plan evaporate the moment he was elected?

So many of our leaders carry a heavy burden of mendacity and avarice. If they instead got in touch with their own souls (perhaps by exposure to the natural world), or made their decisions by maximizing the amount of good that results, our leaders might find real meaning and value in their lives.

Until that happens, the only way to straighten out the current mess is to demand accountability and impose penalties on unethical/dishonest leaders. Both political parties enjoy bounteous hors d'oeuvres from Pharma's table, making it unlikely the existing political "process" will provide relief--as we've seen in the demoralizing healthcare reform drama.

Until then, I'll continue to "call it as I see it" in this blog -- working and living the way life should be, in rural Maine, far from the centers of power.

Ellen Byrne has created several designs encapsulating aspects of the FBI's ridiculous case against Bruce Ivins. They can be purchased on T-shirts and coffee mugs. All proceeds will be donated to the the Frederick County chapter of the American Red Cross, a favored charity of Dr. Bruce Ivins.